Acutus Medical (AFIB) 8-KAcutus Medical Reports Fourth Quarter and Full Year 2022 Financial Results

Revenue was $5.0 million for the fourth quarter of 2022, an increase of 14% compared to $4.4 million for the fourth quarter of 2021. The improvement over the same quarter last year was driven by an increase in commercial AcQMap procedures worldwide, by continued adoption of the Company's differentiated mapping, by an increase in sales of therapy and accessory products and a stabilization in capital sales. Gross margin on a GAAP basis was a negative 68% for the fourth quarter of 2022, compared with negative 128% for the same quarter last year. The improvement was primarily driven by a higher production volume, lower manufacturing variances and a positive impact from restructuring actions taken earlier in the year. The Company will continue to deploy significant resources and focus in improving its gross margin in 2023.

Operating expenses consisting of research & development and selling, general & administrative expenses on a GAAP basis were $15.7 million for the fourth quarter of 2022 compared with $24.7 million for the same quarter last year. Additionally, a one-time gain on the sale of a portion of our business of $35.9 million was responsible for providing a positive bottom line for the fourth quarter of 2022.

Non-GAAP operating expenses were $13.9 million for the fourth quarter of 2022 compared with $21.4 million in the prior year. The decrease of $7.5 million was primarily driven by the reduction in headcount due to restructuring, as well as a reduction in discretionary spend on certain research and development programs.

Net income on a GAAP basis was $15.1 million for the fourth quarter of 2022 and basic net income per share was $0.53 on a weighted average basic outstanding share count of 28.5 million. Diluted net income per share was $0.41 on a weighted average diluted outstanding share count of 37.2 million. For the fourth quarter 2021, net loss was $31.3 million with a basic and diluted net loss per share of $1.12 on a weighted average basic and diluted outstanding share count of 28.0 million.

Excluding income tax expense, amortization of acquired intangibles, non-cash stock-based compensation expense, restructuring charges, change in fair value of warrant liability, change in the fair value of contingent consideration and gain on sale of business, the Company’s non-GAAP net loss for the fourth quarter of 2022 was $17.9 million, or $0.63 per share, compared to a net loss of $28.0 million, or $1.00 per share, for the fourth quarter of 2021.

Gross margin on a GAAP basis was negative 95% for the full year of 2022, compared with negative 91% in the prior year, driven by unfavorable manufacturing variances carried into 2022 from the prior year, idle capacity, and the write-off of excess and obsolete inventory, offset by a partial reduction in manufacturing overhead from the restructuring actions taken in the first half of 2022.

Operating expenses consisting of research & development and selling, general & administrative expenses on a GAAP basis were $75.8 million for the full year of 2022 compared with $100.2 million in the prior year. Non-GAAP operating expenses were $71.5 million for the full year of 2022 compared with $87.0 million in the prior year. The decrease of $15.4 million was a result of realizing the benefits of our cost savings initiatives enacted earlier this year and a reduction in research and development related to the program prioritization.

Net loss on a GAAP basis was $39.6 million for the full year of 2022 and net loss per share was $1.40 on a weighted average basic and diluted outstanding share count of 28.3 million, compared to $117.7 million and a net loss per share of $4.11 on a weighted average basic and diluted outstanding share count of 28.7 million in the prior year.

Excluding income tax expense, amortization of acquired intangibles, non-cash stock-based compensation expense, employee retention credit, goodwill impairment, restructuring charges, changes in the fair value of contingent consideration, gain on sale of business, loss on debt extinguishment and change in fair value of warrant liability, the Company’s non-GAAP net loss for the full year of 2022 was $92.6 million, or $3.27 per share, compared to $107.0 million, or $3.74 per share, for 2021.

Cash, cash equivalents, marketable securities and restricted cash were $76.2 million as of December 31, 2022.

The company expects full year 2023 revenue to be in a range from $18.0-$21.0 million.

This press release includes references to non-GAAP net loss and non-GAAP basic and diluted net loss per share, which are non-GAAP financial measures, to provide information that may assist investors in understanding the Company’s financial results and assessing its prospects for future performance. The Company believes these non-GAAP financial measures are important indicators of its operating performance because they exclude items that are primarily non-cash accounting line items unrelated to, and may not be indicative of, the Company’s core operating results. These non-GAAP financial measures, as Acutus calculates them, may not necessarily be comparable to similarly titled measures of other companies and may not be appropriate measures for comparing the performance of other companies relative to the Company. These non-GAAP financial results are not intended to represent and should not be considered to be more meaningful measures than, or alternatives to, measures of operating performance as determined in accordance with GAAP. Non-GAAP net loss is defined as net loss before income taxes, adjusted for stock-based compensation, amortization of acquisition-related intangibles, employee retention credit, goodwill impairment, restructuring charges, changes in the fair value of contingent consideration, gain on sale of business, loss on debt extinguishment and change in fair value of warrant liability and other adjustments. To the extent such non-GAAP financial measures are used in the future, the Company expects to calculate them using a consistent method from period to period. A reconciliation of the most directly comparable GAAP financial measure to the non-GAAP financial measure has been provided under the heading “Reconciliation of GAAP Results to Non-GAAP Results” in the financial statement tables attached to this press release.

Acutus will host a conference call to discuss the fourth quarter and full year 2022 financial results after market close on Thursday March 16, 2023 at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time. The conference call can be accessed live over the phone (833) 570-1131 for U.S. callers or (914) 987-7078 for international callers, using conference ID: 4985645. The live webinar can be accessed at https://ir.acutusmedical.com.

Acutus is an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated. Acutus is committed to advancing the field of electrophysiology with a unique array of products and technologies which will enable more physicians to treat more patients more efficiently and effectively. Through internal product development, acquisitions and global partnerships, Acutus has established a global sales presence delivering a broad portfolio of highly differentiated electrophysiology products that provide its customers with a complete solution for catheter-based treatment of cardiac arrhythmias. Founded in 2011, Acutus is based in Carlsbad, California.

This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe,” “estimate,” “project,” “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to continue to manage expenses and cash burn rate at sustainable levels, continued acceptance of its products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase the Company’s systems and the timing of such purchases, competitive factors, changes resulting from healthcare policy in the United States and globally including changes in government reimbursement of procedures, dependence upon third-party vendors and distributors, timing of regulatory approvals, the impact of the coronavirus (COVID-19) pandemic and Acutus’ response to it and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, Acutus undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

Procedure volumes for the three months and twelve months ended December 31, 2022 and 2021 are as follows:

The following table sets forth the Company’s revenue for disposables, systems and service/other for both the three months and the twelve months ended December 31, 2022 and 2021 (in thousands):